According to the lawsuits, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that:
- FibroGen’s prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia certain safety analyses submitted in connection with chronic kidney disease (“CKD”) included post-hoc changes to the stratification factors;
- FibroGen’s analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals;
- Based on these analyses, FibroGen could not conclude that roxadustat reduces the risk of (or is superior to) MACE+ in dialysis, and MACE and MACE+ in incident dialysis compared to epoetin-alfa;
- As a result, FibroGen faced significant uncertainty that its New Drug Application for roxadustat as a treatment for anemia of CKD would be approved by the FDA; and
- As a result of the foregoing, defendants’ statements about FibroGen’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
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